David Resnik

A growing body of evidence has linked consumption of trans fatty acids to cardiovascular disease. To promote public health, numerous state and local governments in the United States have banned the use of artificial trans fats in restaurant foods, and additional bans may follow. Although these policies may have a positive impact on human health, they open the door to excessive government control over food, which could restrict dietary choices, interfere with cultural, ethnic, and religious traditions, and exacerbate socioeconomic inequalities. These slippery slope concerns cannot be dismissed as far-fetched, because the social and political pressures are place to induce additional food regulations. To protect human freedom and other values, policies that significantly restrict food choices, such as bans on types of food, should be adopted only when they are supported by substantial scientific evidence, and when policies that impose fewer restrictions on freedom, such as educational campaigns and product labeling, are likely to be ineffective.

Unequal treatment of human research subjects is a significant ethical concern, because justice in research involving human subjects requires equal protection of rights and equal protection from harm and exploitation. Disputes sometimes arise concerning the issue of unequal treatment of research subjects. Allegedly unequal treatment occurs when subjects are treated differently and there is a genuine dispute concerning the appropriateness of equal treatment. Patently unequal treatment occurs when subjects are treated differently and there is not a genuine dispute about the appropriateness of equal treatment. Allegedly unequal treatment will probably always occur in research with human subjects due to disagreements about fundamental questions of justice. The best way to deal with allegedly unequal treatment is to promote honest and open discussions of the issues at stake. Research regulations can help to minimize patently unequal treatment by providing rules for investigators, ethical review boards, institutions, and sponsors to follow. However, patently unequal treatment may still occur because the regulations are subject to interpretation. Federal agencies have provided interpretive guidance that can help promote consistent review and oversight of human subjects research. Additional direction may be needed on topics that are not adequately covered by current guidance or regulations. International guidelines can help promote equal treatment of human subjects around the globe. While minor variations in the treatment of research subjects should be tolerated and even welcomed, major ones (i.e. those that significantly impact human rights or welfare) should be avoided or minimized.

During a prostate exam, Mr. Watson, age 65, learns that his prostate appears to be abnormal. The family physician conducting the exam, Dr. Kleinman, informs Mr. Watson that he may have prostate cancer. Mr. Watson agrees to a variety of tests, including blood tests, bone scans, ultrasound scanning, and a biopsy. After learning about this possible diagnosis and these tests, Mr. Watson surfs the Web for information about prostate cancer and gathers data from many different sources, including the National Cancer Society, the National Institutes of Health, Johns Hopkins University, the Mayo Clinic, and medicine sites. He also searches for information from medical journals using MEDLINE, visits several chat rooms on prostate cancer, and joins some e-mail lists. He arrives in Dr. Kleinman's office for a follow-up appointment with a stack of material and many questions. Dr. Kleinman is surprised, irritated, and offended. He recommends that Mr. Watson have a prostatectomy followed by radiation, but Mr. Watson does not want this operation. He would rather receive a form of radiation therapy recently approved by the FDA that he learned about through his own research. Dr. Kleinman admits that he does not know much about this new treatment, but he says that he would read up on it and consult an oncologist.

I examine the role that approximate truth plays in arguments for convergent realism and diagnose some difficulties that face attempts to defend realism by employing this slippery concept. Approximate truth plays two important roles in convergent realism : it functions as a truth surrogate and it helps explain the success of science. I argue that approximate truth cannot perform both of these roles. If it adequately fulfills its role as a truth surrogate, then it cannot explain the success of science. If it adequately explains the success of science, then it cannot function as a truth surrogate

The Common Rule is a set of regulations for protecting human participants in research funded by the Department of Health and Human Services, which has been adopted in part by 17 federal agencies. It includes four different subparts: Subpart A, Subpart B, Subpart C, and Subpart D. The Common Rule has not been significantly revised since 1981 although some significant changes may be forthcoming. The Food and Drug Administration has adopted its own regulations for the protection of human participants, which are similar to the Common Rule in many key areas, such as the structure and function of the Institutional Review Board, and the criteria for approving research.

Government food and beverage policies can play an important role in promoting public health. Few people would question this assumption. Difficult questions can arise, however, when policymakers, public health officials, citizens, and businesses deliberate about food and beverage policies, because competing values may be at stake, such as public health, individual autonomy, personal responsibility, economic prosperity, and fairness. An ethically justified policy strikes a reasonable among competing values by meeting the following criteria: the policy serves important social goal; the policy is likely to be effective at achieving those goal; less burdensome options are not likely to be effective at achieving the goals; the policy is fair

This article reports the results of an anonymous survey of researchers at a government research institution concerning their perceptions about ethical problems with journal peer review. Incompetent review was the most common ethical problem reported by the respondents, with 61.8% (SE = 3.3%) claiming to have experienced this at some point during peer review. Bias (50.5%, SE = 3.4%) was the next most common problem. About 22.7% (SE = 2.8%) of respondents said that a reviewer had required them to include unnecessary references to his/her publication(s), 17.7% (SE = 2.6%) said that comments from reviewers had included personal attacks, and 9.6% (SE = 2.0%) stated that reviewers had delayed publication to publish a paper on the same topic. Two of the most serious violations of peer review ethics, breach of confidentiality (6.8%, SE = 1.7%) and using ideas, data, or methods without permission (5%, SE = 1.5%) were perceived less often than the other problems. We recommend that other investigators follow up on our exploratory research with additional studies on the ethics of peer review.

This study discusses the results of a survey of 1,800 articles published in American medical journals from 1985--1996. The study finds 9% of these articles reported research that uses only male subjects to examine medical conditions that affect both sexes; the ratio of research on female to male conditions among these articles was greater than 5:1; but 76.5% of the articles reported research that includes both male and female subjects. The study also discusses evidence that sex biases against women (and men) are decreasing. This study also offers some possible psychological, institutional, medical, and economic explanations of the sex biases in medical research published in American journals, and discusses some policy implications of sex biases in medical research. The study concludes by urging others to conduct more empirical research on sex biases in medical research.

The US federal research regulations prohibit informed consent, whether written or oral, from including provisions in which human subjects waive or appear to waive legal rights. We argue that policies that prevent human subjects from waiving legal rights in research can be ethically justified under the rationale of group, soft paternalism. These policies protect competent adults from making adverse decisions about health and legal matters that they may not understand fully. However, this rationale is less defensible if there is a comprehensive compensation for injury programme available in which subjects are asked to waive some legal rights in order to participate in the programme. In this situation, subjects should be allowed to waive some legal rights to obtain the benefits of the programme

This paper defends two principles of methodological conservatism on the grounds that they help to promote an effective social structure for a knowledge‐seeking community. Conservatism has some prima facie justification because it provides for an effective division of cognitive labor, it promotes the effective use of scientific resources, and it provides for a certain amount of stability. However, the principles I defend in this paper should not be treated as absolute or unconditional criteria of theory‐choice, since they can be overridden by other rules or maxims. Since the decision to override a principle of conservatism depends on various contextual factors, the appropriateness of conservatism can vary from context to context.

This essay provides an explanation and interpretation of the undertreatment of pain by discussing some of the scientific, clinical, cultural, and philosophical aspects of this problem. One reason why pain continues to be a problem for medicine is that pain does not conform to the scientific approach to health and disease, a philosophy adopted by most health care professionals. Pain does not fit this philosophical perspective because (1) pain is subjective, not objective; (2) the causal basis of pain is often poorly understood; (3) pain is often regarded as a mere symptom, not as a disease; (4) there often are no magic bullets for pain; (5) pain does not fit the expert knowledge model. In order for health care professionals to do a better job of treating pain, some changes need to occur in medical philosophy, education, and practice.

In his book The Evolution of Individuality, Leo Buss attacks a central dogma of the neo-Darwinian (or synthetic) theory of evolution, the idea that the individual is the sole unit of selection, by arguing that individuals themselves emerged as the result of selective forces that regulated the replication of cell lineages for the benefit of the whole organism. Buss also argues that metazoan developmental patterns and life cycles are the products of selection operating on different units of selection, and that there have been transitions between different units of selection during the history of life. Despite the revolutionary character of this book, The Evolution of Individuality in many ways reflects the adaptationist thinking often associated with the synthetic theory. Buss' framework could be improved by giving further consideration to chance factors in the evolution of development, and examining the details of the evolution of ontogeny in more depth.

This paper examines a new challenge to neo-Darwinism, a movement known as process structuralism. The process structuralist critique of neo-Darwinism holds 1) that there are general laws in biology and that biologists should search for these laws; 2) that there are general forms of morphology and development and that biologists should attempt to uncover these forms; 3) that organisms are unified wholes that cannot be understood without adopting a holistic perspective; and 4) that no special, causal primacy should be given to the genes in development and morphology. This paper places process structuralism in its historical context, examines the philosophical underpinnings of the movement, and discusses some of the evidence used to support its claims.

In this article, we argue that the scope of bioethical debate concerning justice in health should expand beyond the topic of access to health care and cover such issues as occupational hazards, safe housing, air pollution, water quality, food and drug safety, pest control, public health, childhood nutrition, disaster preparedness, literacy, and many other environmental factors that can cause differences in health. Since society does not have sufficient resources to address all of these environmental factors at one time, it is important to set priorities for bioethical theorizing and policy formation. Two considerations should be used to set these priorities: (1) the impact of the environmental factor on health inequality, and (2) the practicality of addressing the factor.

This paper discusses the economic, legal, moral, and political difficulties in developing drugs for the developing world. It argues that large, global pharmaceutical companies have social responsibilities to the developing world, and that they may exercise these responsibilities by investing in research and development related to diseases that affect developing nations, offering discounts on drug prices, and initiating drug giveaways. However, these social responsibilities are not absolute requirements and may be balanced against other obligations and commitments in light of economic, social, legal, political, and other conditions. How a company decides to exercise its social responsibilities to the developing world depends on the prospects for a reasonable profit and the prospects for a productive business environment. Developing nations can either help or hinder the pharmaceutical industry’s efforts to exercise social responsibility through various policies and practices. To insure that companies can make a reasonable profit, developing nations should honor pharmaceutical product patents and adhere to international intellectual property treaties, such as the Trade‐Related Aspects of Intellectual Property Rights agreement. To insure the companies have a good business environment, developing nations should try to promote the rule of law, ethical business practices, stable currencies, reliable banking systems, free and open markets, democracy, and other conditions conducive to business. Overall, this paper advocates for reciprocity and cooperation between pharmaceutical companies and developing nations to address the problem of developing drugs for the developing world. In pursuing this cooperative approach, developing nations may use a variety of other techniques to encourage pharmaceutical companies to act responsibly, such as subsidizing pharmaceutical research, helping to design and implement research protocols, providing a guaranteed market, and bulk buying.

: This essay provides an analysis of conflicts of interest in science. It gives an overview of some current conflict of interest policies and distinguishes between real, apparent, and potential conflicts of interest. The essay argues that scientists should disclose real, apparent, and potential conflicts of interest and that they should avoid conflicts that threaten scientific objectivity or trustworthiness. The essay also uses several hypothetical scenarios to illustrate some of the key points made in the analysis and suggests some strategies for buffering the impact of conflicts of interest in science